Newborn Phosphocalcic Metabolism After Intravenous Iron Administration During Pregnancy

Sponsor

University Hospital, Geneva (Other)

Overall Status

Completed

CT.gov ID

NCT06108258

Collaborator

(none)

Enrollment

Location

5.3

Actual Duration (Months)

8.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Iron deficiency anemia (IDA) is a very common health problem during pregnancy and intravenous (IV) iron substitution has become part of routine management. Recent studies have raised concerns about association of IV iron infusion and development of secondary transitory hypophosphatemia (HP) in adults including pregnant women. The study aimed to evaluate the impact of IV iron administration during pregnancy on newborn's phosphatemia.

The investigators conducted a prospective, single-center, observational study in the Geneva University Hospitals (HUG), from September 2022 to March 2023. Pregnant women treated either with IV iron or with oral iron during pregnancy were included. At delivery, a maternal blood sample to assess hemoglobin, hematocrit, ferritin, phosphate and calcium and an umbilical cord blood sample to assess levels of phosphate and calcium were collected. Difference in demographics and clinical characteristics between the two groups were explored using univariate analyses. Multivariate analyses were performed to test the contribution of IV iron substitution on cord blood phosphatemia and calcemia, considering potential confounding factors. Neonatal HP was defined as a phosphate level lower than 1.3 mmol/L.

Condition or Disease	Intervention/Treatment	Phase
Iron Induced Hypophosphatemia	Drug: IV iron administration

Study Design

Study Type:

Observational

Actual Enrollment :

43 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Newborn Phosphocalcic Metabolism After Intravenous Iron Administration During Pregnancy

Actual Study Start Date :

Sep 23, 2022

Actual Primary Completion Date :

Mar 3, 2023

Actual Study Completion Date :

Mar 3, 2023

Arms and Interventions

Arm	Intervention/Treatment
Oral iron
IV iron	Drug: IV iron administration IV iron administration during pregnancy

Arm

Intervention/Treatment

Oral iron

IV iron

Drug: IV iron administration

IV iron administration during pregnancy

Outcome Measures

Primary Outcome Measures

Concentration of cord blood phosphate in neonates [Single timepoint at delivery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Single pregnancy
Term (>37SA) pregnancy
Oral or IV iron substitution from second trimester

Exclusion Criteria:

Multiple pregnancy
Fetal anomalies
Preterm birth

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Geneva University Hospitals	Geneva		Switzerland

Sponsors and Collaborators

University Hospital, Geneva

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fanny Schumacher, resident doctor, University Hospital, Geneva

ClinicalTrials.gov Identifier:

NCT06108258

Other Study ID Numbers:

2022-00197

First Posted:

Oct 30, 2023

Last Update Posted:

Oct 30, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypophosphatemia

Study Results

No Results Posted as of Oct 30, 2023